BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7010 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter phone: (b)(6).Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter.The device was microscopically and visually examined.At 36.8cm distal from the strain relief, the hypotube was separated.At 31.9cm distal from the separation, the hypotube was separated a second time.The separated ends were ovaled in shape indicating the device was likely kinked prior to separation.There were numerous kinks to the hypotube of the device.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Product analysis and media provided confirmed the reported kink.Analysis found that there were numerous kinks to the hypotube of the device, and also unreported separation of the hypotube in two different locations.
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Event Description
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Reportable based on device analysis completed on 30jun2023.It was reported that shaft kink occurred.A 4.0mm x 12mm quantum maverick balloon catheter was selected for used.However, after unpacking, it was noted that the device was kinked.The procedure was completed with another of the same device.There were no patient complications reported, and the patient was stable post-procedure.However, returned device analysis revealed that the hypotube was detached/separated.
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Search Alerts/Recalls
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